FDA 510(k)

貝魯爾 IPL 5500 裝置/ IPL 5000/ IPL PureSkin Pro

K 號：K181121 · 2018-06-28

決定日期2018-06-28

產品代碼OHT

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is the device name listed in this FDA 510(k) record. The listed applicant is Home Well Trading, Ltd.. It received FDA 510(k) clearance on 2018-06-28 under 510(k) number K181121. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro?

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Home Well Trading, Ltd.. The 510(k) number is K181121.

When did Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro receive FDA 510(k) clearance?

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro received FDA 510(k) clearance on 2018-06-28, under 510(k) number K181121.

Who is the listed applicant for Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro?

The FDA 510(k) record lists Home Well Trading, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro?

The FDA product code for Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is OHT.

其他以 Home Well Trading, Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K181734貝魯爾 IPL 8500 裝置/ IPL VelvetSkin Pro

相關器械（代碼：OHT）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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